Monoclonal
antibody (mAb) products are extraordinarily
heterogeneous due to the presence of a variety of enzymatic and chemical
modifications, such as deamidation, isomerization, oxidation,
glycosylation, glycation, terminal cyclization, aggregation, and fragmentation.
Forced
degradation study is a common practice to assess the potential modifications
and degradation pathways of mAbs upon extreme conditions, including light
exposure and extreme local pH.
The degraded
samples are subject to characterization using a wide array of analyses,
including ion exchange chromatography (IEC) for charge variants and size
exclusion chromatography (SEC) for size variants.
